Scar FormationPhase 1/2NCT01750424
3-D Imaging Assessment of Scar Formation and Would Healing in Fat Grafted vs Non-Fat Grafted Facial Reconstruction Wound Sites
A Phase 1/2 study testing Autologous Fat Grafting in people with Scar Formation and Autologous Fat Grafting, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to assess scar-formation and wound healing following the use of autologous fat grafting in facial reconstruction patients. Patients who have undergone facial reconstruction in the last 3 months will be randomized into two groups, one receiving fat grafting and one not receiving any… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scar Formation, Autologous Fat Grafting
- What is being tested?
- Autologous Fat Grafting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy Subjects
- Facial reconstruction surgery in the last 3 months
Who cannot join
- Age less than 18 years
- Patients undergoing skin grafting
- Patients undergoing secondary intent closure
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
The purpose of this study is to assess scar-formation and wound healing following the use of autologous fat grafting in facial reconstruction patients. Patients who have undergone facial reconstruction in the last 3 months will be randomized into two groups, one receiving fat grafting and one not receiving any intervention. These patients will continue to follow-up in our clinic for one year, with 3-D images taken at each follow-up visit to assess scar formation and wound healing. Assessment of the scar will be undertaken by both healthcare personnel as well as general lay public. We hypothesize that patients undergoing fat grafting to the wound site will achieve a more aesthetically appealing result, with less scarring and improved wound healing as judged by both the general public and healthcare professionals.
Read the detailed description
A variety of local and regional skin flaps are used for reconstruction of skin defects on the face with the intention of full wound closure, healing, and scar minimization. Scarring is an unavoidable consequence of wound healing, especially after significant facial reconstruction. Fibroblasts migrate to the injurious site where they proliferate and deposit collagen. The collagenous proteins serve to fill in the wound defect and allow epithelial cells to accumulate and repopulate the skin surface. The collagenous base is subsequently exchanged for various types of collagen and is crosslinked. Although scar formation is an important component of wound healing, patients develop scars differently based upon location and biology of the subject. Excessive scar formation may result from excessive collagen production and inadequate collagen remodeling (Gurtner).
Much effort has focused on minimizing scar formation. Such techniques have included rigorous sterilization techniques, smaller, more linear incisions, and incisions that follow normal tension lines in the skin to name only a few. However, these techniques have been mostly limited to intraoperative or pre-operative measures. And while successful in minimizing scar burden, these techniques do not address scar management post operatively.
Wound healing and scar formation follow complex biological processes dependent on inflammatory cells and growth factors. It has been shown in utero that fetal wounds are capable of scarless healing during a phase of gestation when wounds heal with a paucity of inflammatory cells (Soo, Frantz). This principle was further studied in immune deficient mice lacking both macrophages and neutrophils, which are critical to the inflammatory response. Within this experiment, both groups of mice (immunodeficient and normal mice) healed the wounds, the immunodeficient mice did so in a scarless manner (Mori, Martin). Extrapolating this information to current surgical patients, the development of an immunomodulating measure is critical to inhibiting and managing scar formation.
Adipose derived mesenchymal stem cells (ADSCs) have been studied with regard to their role in the wound healing and scar formation process and have shown great promise. In experimental studies, ADSCs have shown to promote angiogenesis, granulation and reepithelialization of the overlying wound (Ebrahimian). Whether directly or indirectly through these processes, the ADSCs also improve the appearance of resultant scars by decreasing size, contrast of scar color, and improving pliability of the scar (Blanton, Yun). However, it is not to be confused that all adipose tissue is equivalent with ADSCs. Rather, ADSCs are a particular line of cells found within adipose tissue that have the unique capability of differentiating into a variety of types of tissues, from bone to cartilage to further adipose tissue (Zuk). These cells are capable of being harvested and cultured from adipose tissue within subjects and then subsequently injected into the wound site of interest.
Fat grafting is a similar but less involved technique that harvests autologous adipose tissue but does not use cell culture techniques to isolate ADSCs from other cell lineages. Fat grafting has long been used as a technique concurrently with facial reconstruction procedures and facial rejuvenation procedures as a "filler" of sorts for facial augmentation as early as 1893 (Miller). The fat injected into the face serves as a volume expander to correct defects related to loss of muscle or bone, such as in micrognathia. Since those initial trials, the technique has been widely expanded and honed to provide the best possible contouring. In addition to the filler aspects and results of the procedure, the technique has been observed to improve skin quality in injection sites, improve pigmentation irregularities, and even improve appearance of long standing scars. However, a formal study of fat grafting's potential of improved wound healing and minimization of scar formation has never been undertaken.
Although not identical to the process of injection of autologous ADSCs, the process of fat grafting has the capabilities of providing some number of ADSCs that were in the adipose harvest. Additionally, the process itself has been shown in the past to improve previously existing scars and improve the quality of skin overlying injection sites (Coleman). Therefore, it is logical to assume that injection of autologous fat will improve wound healing and minimize scar formation in patients undergoing the procedure through effects of ADSCs within the harvested tissue.
With the advent of advanced 3-D imaging technology, we are now able to obtain high-quality, high-resolution images to document and detail stages of wound healing and scar formation. Therefore, we will be able to determine through observer analysis whether the process of fat grafting changes the formation and quality of scars over time.
- Conditions
- Scar Formation, Autologous Fat Grafting
- Being tested
- Autologous Fat Grafting, No intervention
- Keywords
- Scar, Fat Grafting, Adipose Grafting, 3-D imaging, Manchester Scar Scale
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat GraftingProcedure or surgery
Also called Fat Grafting, Adipose Grafting
No interventionOther
Subjects in this arm will only be followed up and have no procedure performed.
| Study group | Role | What they receive |
|---|---|---|
| Fat Grafted | Experimental | The experimental arm of the study will be composed of 15 patients who undergo autologous fat grafting into the site of the facial reconstructive scar at 3 months post-operatively. A small amount of fat will be removed near the umbilicus through a cannula using local anesthetic and a small, 2-3mm incision just barely large enough for the cannula to pass. That fat will be injected directly under the scar site in those patients using a similar cannula, local anesthetic, and small, 2-3mm incision. No sutures will be required at either the donor or injection site. Patients will subsequently return to clinic for 3-D photographic assessment at 3, 6 and 12 months post-fat grafting. The images generated at each session will be provided to a group of assessors for evaluation. They will either use the Manchester Scar Scale or the modified Manchester Scar Scale depending on whether they are within the health care profession. Receives: Procedure: Autologous Fat Grafting |
| Non-fat grafted | Placebo comparator | The control arm will be composed of 15 patients who undergo no intervention. These patients will be identified at 3 months post-operatively from their facial reconstruction. They will undergo no fat-grafting but will be followed up with the same frequency as the experimental group, at 3 months, 6 months, and 12 months after their initial 3 month post-surgical follow-up. 3-D images will be taken at each appointment and will be distributed to all assessors. Assessors will use either the Manchester Scar Scale or a modified Manchester Scar Scale to evaluate the appearance of the scar at each time point. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale
An independent group of observers/evaluators, consisting of medical students and other non-faculty medical personnel as well as general lay observers, will be asked to view the 3-D images from each time point, evaluate the aesthetic outcome, and grade the scars presented in each case. Scales used will be the Manchester Scar Scale, which has been used previously for photographic scar assessment, as well as a more lay-person's version of the Manchester Scar scale created for the use of an average observer. These forms assess the color, hypertrophy, vascularity, etc of the scar as compared to surrounding skin. The data collected will be analyzed using appropriate statistical software and/or calculations.
Measured: 3 months post-fat grafting
Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale
An independent group of observers/evaluators, consisting of medical students and other non-faculty medical personnel as well as general lay observers, will be asked to view the 3-D images from each time point, evaluate the aesthetic outcome, and grade the scars presented in each case. Scales used will be the Manchester Scar Scale, which has been used previously for photographic scar assessment, as well as a more lay-person's version of the Manchester Scar scale created for the use of an average observer. These forms assess the color, hypertrophy, vascularity, etc of the scar as compared to surrounding skin. The data collected will be analyzed using appropriate statistical software and/or calculations.
Measured: 6 months post-fat grafting
Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale
An independent group of observers/evaluators, consisting of medical students and other non-faculty medical personnel as well as general lay observers, will be asked to view the 3-D images from each time point, evaluate the aesthetic outcome, and grade the scars presented in each case. Scales used will be the Manchester Scar Scale, which has been used previously for photographic scar assessment, as well as a more lay-person's version of the Manchester Scar scale created for the use of an average observer. These forms assess the color, hypertrophy, vascularity, etc of the scar as compared to surrounding skin. The data collected will be analyzed using appropriate statistical software and/or calculations.
Measured: 12 months post-fat grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Scar FormationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek Steinbacher, MD, DMD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750424
- Sponsor's protocol ID
- HIC-1209010842
- Status last verified
- Sep 2016
- First submitted
- 12 Dec 2012
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Soo C, Hu FY, Zhang X, Wang Y, Beanes SR, Lorenz HP, Hedrick MH, Mackool RJ, Plaas A, Kim SJ, Longaker MT, Freymiller E, Ting K. Differential expression of fibromodulin, a transforming growth factor-beta modulator, in fetal skin development and scarless repair. Am J Pathol. 2000 Aug;157(2):423-33. doi: 10.1016/s0002-9440(10)64555-5.
PubMed 10934147Frantz FW, Bettinger DA, Haynes JH, Johnson DE, Harvey KM, Dalton HP, Yager DR, Diegelmann RF, Cohen IK. Biology of fetal repair: the presence of bacteria in fetal wounds induces an adult-like healing response. J Pediatr Surg. 1993 Mar;28(3):428-33; discussion 433-4. doi: 10.1016/0022-3468(93)90243-e.
PubMed 8468658Mori R, Shaw TJ, Martin P. Molecular mechanisms linking wound inflammation and fibrosis: knockdown of osteopontin leads to rapid repair and reduced scarring. J Exp Med. 2008 Jan 21;205(1):43-51. doi: 10.1084/jem.20071412. Epub 2008 Jan 7.
PubMed 18180311Cooper L, Johnson C, Burslem F, Martin P. Wound healing and inflammation genes revealed by array analysis of 'macrophageless' PU.1 null mice. Genome Biol. 2005;6(1):R5. doi: 10.1186/gb-2004-6-1-r5. Epub 2004 Dec 23.
PubMed 15642097Ebrahimian TG, Pouzoulet F, Squiban C, Buard V, Andre M, Cousin B, Gourmelon P, Benderitter M, Casteilla L, Tamarat R. Cell therapy based on adipose tissue-derived stromal cells promotes physiological and pathological wound healing. Arterioscler Thromb Vasc Biol. 2009 Apr;29(4):503-10. doi: 10.1161/ATVBAHA.108.178962. Epub 2009 Feb 5.
PubMed 19201690Blanton MW, Hadad I, Johnstone BH, Mund JA, Rogers PI, Eppley BL, March KL. Adipose stromal cells and platelet-rich plasma therapies synergistically increase revascularization during wound healing. Plast Reconstr Surg. 2009 Feb;123(2 Suppl):56S-64S. doi: 10.1097/PRS.0b013e318191be2d.
PubMed 19182664Yun IS, Jeon YR, Lee WJ, Lee JW, Rah DK, Tark KC, Lew DH. Effect of human adipose derived stem cells on scar formation and remodeling in a pig model: a pilot study. Dermatol Surg. 2012 Oct;38(10):1678-88. doi: 10.1111/j.1524-4725.2012.02495.x. Epub 2012 Jul 16.
PubMed 22804839Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH. Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95. doi: 10.1091/mbc.e02-02-0105.
PubMed 12475952Miller JJ, Popp JC. Fat hypertrophy after autologous fat transfer. Ophthalmic Plast Reconstr Surg. 2002 May;18(3):228-31. doi: 10.1097/00002341-200205000-00015.
PubMed 12021657Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.
PubMed 16936550Gurtner GC. Wound Healing: Normal and Abnormal. In: Thorne C, Beasley RW, Aston SJ, Bartlett SP, Gurtner GC, Spear SL, eds. Grabb and Smith's Plastic Surgery. Sixth ed: Philadelphia, PA : Lippincott Williams & Wilkins; 2007.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-D Imaging Assessment of Scar Formation and Would Healing in Fat Grafted vs Non-Fat Grafted Facial Reconstruction Wound Sites
- ClinicalTrials.gov ID
- NCT01750424
- Acronym / sponsor ID
- HIC-1209010842
- Conditions
- Scar Formation, Autologous Fat Grafting
- Keywords
- Scar, Fat Grafting, Adipose Grafting, 3-D imaging, Manchester Scar Scale
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess scar-formation and wound healing following the use of autologous fat grafting in facial reconstruction patients. Patients who have undergone facial reconstruction in the last 3 months will be randomized into two groups, one receiving fat grafting and one not receiving any intervention. These patients will continue to follow-up in our clinic for one year, with 3-D images taken at each follow-up visit to assess scar formation and wound healing. Assessment of the scar will be undertaken by both healthcare personnel as well as general lay public. We hypothesize that patients undergoing fat grafting to the wound site will achieve a more aesthetically appealing result, with less scarring and improved wound healing as judged by both the general public and healthcare professionals.
Detailed description
A variety of local and regional skin flaps are used for reconstruction of skin defects on the face with the intention of full wound closure, healing, and scar minimization. Scarring is an unavoidable consequence of wound healing, especially after significant facial reconstruction. Fibroblasts migrate to the injurious site where they proliferate and deposit collagen. The collagenous proteins serve to fill in the wound defect and allow epithelial cells to accumulate and repopulate the skin surface. The collagenous base is subsequently exchanged for various types of collagen and is crosslinked. Although scar formation is an important component of wound healing, patients develop scars differently based upon location and biology of the subject. Excessive scar formation may result from excessive collagen production and inadequate collagen remodeling (Gurtner).
Much effort has focused on minimizing scar formation. Such techniques have included rigorous sterilization techniques, smaller, more linear incisions, and incisions that follow normal tension lines in the skin to name only a few. However, these techniques have been mostly limited to intraoperative or pre-operative measures. And while successful in minimizing scar burden, these techniques do not address scar management post operatively.
Wound healing and scar formation follow complex biological processes dependent on inflammatory cells and growth factors. It has been shown in utero that fetal wounds are capable of scarless healing during a phase of gestation when wounds heal with a paucity of inflammatory cells (Soo, Frantz). This principle was further studied in immune deficient mice lacking both macrophages and neutrophils, which are critical to the inflammatory response. Within this experiment, both groups of mice (immunodeficient and normal mice) healed the wounds, the immunodeficient mice did so in a scarless manner (Mori, Martin). Extrapolating this information to current surgical patients, the development of an immunomodulating measure is critical to inhibiting and managing scar formation.
Adipose derived mesenchymal stem cells (ADSCs) have been studied with regard to their role in the wound healing and scar formation process and have shown great promise. In experimental studies, ADSCs have shown to promote angiogenesis, granulation and reepithelialization of the overlying wound (Ebrahimian). Whether directly or indirectly through these processes, the ADSCs also improve the appearance of resultant scars by decreasing size, contrast of scar color, and improving pliability of the scar (Blanton, Yun). However, it is not to be confused that all adipose tissue is equivalent with ADSCs. Rather, ADSCs are a particular line of cells found within adipose tissue that have the unique capability of differentiating into a variety of types of tissues, from bone to cartilage to further adipose tissue (Zuk). These cells are capable of being harvested and cultured from adipose tissue within subjects and then subsequently injected into the wound site of interest.
Fat grafting is a similar but less involved technique that harvests autologous adipose tissue but does not use cell culture techniques to isolate ADSCs from other cell lineages. Fat grafting has long been used as a technique concurrently with facial reconstruction procedures and facial rejuvenation procedures as a "filler" of sorts for facial augmentation as early as 1893 (Miller). The fat injected into the face serves as a volume expander to correct defects related to loss of muscle or bone, such as in micrognathia. Since those initial trials, the technique has been widely expanded and honed to provide the best possible contouring. In addition to the filler aspects and results of the procedure, the technique has been observed to improve skin quality in injection sites, improve pigmentation irregularities, and even improve appearance of long standing scars. However, a formal study of fat grafting's potential of improved wound healing and minimization of scar formation has never been undertaken.
Although not identical to the process of injection of autologous ADSCs, the process of fat grafting has the capabilities of providing some number of ADSCs that were in the adipose harvest. Additionally, the process itself has been shown in the past to improve previously existing scars and improve the quality of skin overlying injection sites (Coleman). Therefore, it is logical to assume that injection of autologous fat will improve wound healing and minimize scar formation in patients undergoing the procedure through effects of ADSCs within the harvested tissue.
With the advent of advanced 3-D imaging technology, we are now able to obtain high-quality, high-resolution images to document and detail stages of wound healing and scar formation. Therefore, we will be able to determine through observer analysis whether the process of fat grafting changes the formation and quality of scars over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fat Grafted | Experimental | Procedure: Autologous Fat GraftingThe experimental arm of the study will be composed of 15 patients who undergo autologous fat grafting into the site of the facial reconstructive scar at 3 months post-operatively. A small amount of fat will be removed near the umbilicus through a cannula using local anesthetic and a small, 2-3mm incision just barely large enough for the cannula to pass. That fat will be injected directly under the scar site in those patients using a similar cannula, local anesthetic, and small, 2-3mm incision. No sutures will be required at either the donor or injection site. Patients will subsequently return to clinic for 3-D photographic assessment at 3, 6 and 12 months post-fat grafting. The images generated at each session will be provided to a group of assessors for evaluation. They will either use the Manchester Scar Scale or the modified Manchester Scar Scale depending on whether they are within the health care profession. |
| Non-fat grafted | Placebo comparator | Other: No interventionThe control arm will be composed of 15 patients who undergo no intervention. These patients will be identified at 3 months post-operatively from their facial reconstruction. They will undergo no fat-grafting but will be followed up with the same frequency as the experimental group, at 3 months, 6 months, and 12 months after their initial 3 month post-surgical follow-up. 3-D images will be taken at each appointment and will be distributed to all assessors. Assessors will use either the Manchester Scar Scale or a modified Manchester Scar Scale to evaluate the appearance of the scar at each time point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Subjects
- Facial reconstruction surgery in the last 3 months
Key exclusion criteria (3 listed)
- Age less than 18 years
- Patients undergoing skin grafting
- Patients undergoing secondary intent closure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Fat GraftingAlso: Fat Grafting, Adipose Grafting | Procedure or surgery | Fat Grafted |
| No interventionSubjects in this arm will only be followed up and have no procedure performed. | Other | Non-fat grafted |
Primary outcome
Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale
Time frame: 3 months post-fat grafting
An independent group of observers/evaluators, consisting of medical students and other non-faculty medical personnel as well as general lay observers, will be asked to view the 3-D images from each time point, evaluate the aesthetic outcome, and grade the scars presented in each case. Scales used will be the Manchester Scar Scale, which has been used previously for photographic scar assessment, as well as a more lay-person's version of the Manchester Scar scale created for the use of an average observer. These forms assess the color, hypertrophy, vascularity, etc of the scar as compared to surrounding skin. The data collected will be analyzed using appropriate statistical software and/or calculations.
Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale
Time frame: 6 months post-fat grafting
An independent group of observers/evaluators, consisting of medical students and other non-faculty medical personnel as well as general lay observers, will be asked to view the 3-D images from each time point, evaluate the aesthetic outcome, and grade the scars presented in each case. Scales used will be the Manchester Scar Scale, which has been used previously for photographic scar assessment, as well as a more lay-person's version of the Manchester Scar scale created for the use of an average observer. These forms assess the color, hypertrophy, vascularity, etc of the scar as compared to surrounding skin. The data collected will be analyzed using appropriate statistical software and/or calculations.
Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale
Time frame: 12 months post-fat grafting
An independent group of observers/evaluators, consisting of medical students and other non-faculty medical personnel as well as general lay observers, will be asked to view the 3-D images from each time point, evaluate the aesthetic outcome, and grade the scars presented in each case. Scales used will be the Manchester Scar Scale, which has been used previously for photographic scar assessment, as well as a more lay-person's version of the Manchester Scar scale created for the use of an average observer. These forms assess the color, hypertrophy, vascularity, etc of the scar as compared to surrounding skin. The data collected will be analyzed using appropriate statistical software and/or calculations.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Background: PubMed 10934147Soo C, Hu FY, Zhang X, Wang Y, Beanes SR, Lorenz HP, Hedrick MH, Mackool RJ, Plaas A, Kim SJ, Longaker MT, Freymiller E, Ting K. Differential expression of fibromodulin, a transforming growth factor-beta modulator, in fetal skin development and scarless repair. Am J Pathol. 2000 Aug;157(2):423-33. doi: 10.1016/s0002-9440(10)64555-5.
- Background: PubMed 8468658Frantz FW, Bettinger DA, Haynes JH, Johnson DE, Harvey KM, Dalton HP, Yager DR, Diegelmann RF, Cohen IK. Biology of fetal repair: the presence of bacteria in fetal wounds induces an adult-like healing response. J Pediatr Surg. 1993 Mar;28(3):428-33; discussion 433-4. doi: 10.1016/0022-3468(93)90243-e.
- Background: PubMed 18180311Mori R, Shaw TJ, Martin P. Molecular mechanisms linking wound inflammation and fibrosis: knockdown of osteopontin leads to rapid repair and reduced scarring. J Exp Med. 2008 Jan 21;205(1):43-51. doi: 10.1084/jem.20071412. Epub 2008 Jan 7.
- Background: PubMed 15642097Cooper L, Johnson C, Burslem F, Martin P. Wound healing and inflammation genes revealed by array analysis of 'macrophageless' PU.1 null mice. Genome Biol. 2005;6(1):R5. doi: 10.1186/gb-2004-6-1-r5. Epub 2004 Dec 23.
- Background: PubMed 19201690Ebrahimian TG, Pouzoulet F, Squiban C, Buard V, Andre M, Cousin B, Gourmelon P, Benderitter M, Casteilla L, Tamarat R. Cell therapy based on adipose tissue-derived stromal cells promotes physiological and pathological wound healing. Arterioscler Thromb Vasc Biol. 2009 Apr;29(4):503-10. doi: 10.1161/ATVBAHA.108.178962. Epub 2009 Feb 5.
- Background: PubMed 19182664Blanton MW, Hadad I, Johnstone BH, Mund JA, Rogers PI, Eppley BL, March KL. Adipose stromal cells and platelet-rich plasma therapies synergistically increase revascularization during wound healing. Plast Reconstr Surg. 2009 Feb;123(2 Suppl):56S-64S. doi: 10.1097/PRS.0b013e318191be2d.
- Background: PubMed 22804839Yun IS, Jeon YR, Lee WJ, Lee JW, Rah DK, Tark KC, Lew DH. Effect of human adipose derived stem cells on scar formation and remodeling in a pig model: a pilot study. Dermatol Surg. 2012 Oct;38(10):1678-88. doi: 10.1111/j.1524-4725.2012.02495.x. Epub 2012 Jul 16.
- Background: PubMed 12475952Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH. Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95. doi: 10.1091/mbc.e02-02-0105.
- Background: PubMed 12021657Miller JJ, Popp JC. Fat hypertrophy after autologous fat transfer. Ophthalmic Plast Reconstr Surg. 2002 May;18(3):228-31. doi: 10.1097/00002341-200205000-00015.
- Background: PubMed 16936550Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.
- BackgroundGurtner GC. Wound Healing: Normal and Abnormal. In: Thorne C, Beasley RW, Aston SJ, Bartlett SP, Gurtner GC, Spear SL, eds. Grabb and Smith's Plastic Surgery. Sixth ed: Philadelphia, PA : Lippincott Williams & Wilkins; 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Steinbacher, MD, DMD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Fat Grafting in people with Scar Formation and Autologous Fat Grafting, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale (time frame: 3 months post-fat grafting). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750424, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.